International IBD Genetics Consortium

Transcription

1 International IBD Genetics Consortium PRED4 Proton Pump Inhibitor Induced Nephritis Case Report FormS Please stick study label here On completion, please return to: IBD Pharmacogenetics Research Office The Research, Innovation, Learning and Development Centre (RILD) Barrack Road Exeter EX2 5DW

2 Introduction Please complete all boxes where indicated and in black ball point pen. If you make a mistake please put a line through the box, initial and date and write answer to the side. Complete dates in format dd/mm/yyyy The patient identification number is the bar code on the front of the CRF. Please transcribe this on to the top of the page in each relevant section. For study inclusion participants must meet all the major criteria and any number of the additional 5 minor criteria. A diagnosis of PPI induced nephrotoxicity will be most confident in patients with all 5 minor criteria and least confident in those with no additional minor criteria. *Other risk factors Drugs Penicillins, Cephalosporins, Ciprofloxacin, Sulphonamides, Rifampicin, Frusemide, Bumetanide, Thiazides, Allopurinol, Cimetidine, Indinavir, 5- ASA Comorbidities Uncontrolled hypertension, Diabetes, severe peripheral vascular disease Page 2 of 11 International IBD Genetics Consortium

3 Section 1 - Inclusion Criteria 1.1 Major criteria (all must be met) 30% rise in serum creatinine or 25% fall in egfr any time after introduction of PPI No other risk factors for renal disease (see page 2)* at the time of the renal injury Medical opinion implicating PPI justifies drug withdrawal, even if temporary 1.2 Minor criteria Normal creatinine at baseline Rise in serum creatinine or fall in egfr occurs within 12 months of introduction of PPI Renal biopsy demonstrates interstitial nephritis 25% improvement in peak creatinine or lowest egfr on withdrawal of PPI, with or without use of steroids Re-challenge with any PPI leads to 30% rise in serum creatinine or 25% fall in egfr any time after introduction 1.3 Number of minor criteria 1.4 Participant s eligibility Investigator sign-off Is the participant eligible to take part in the clinical trial? Yes No If no, please give reason(s) for screen failure: Investigator s signature Date Investigator s name (print) International IBD Genetics Consortium Page 3 of 11

4 Section 2 - Patient Details 2.1 Patient details Date of Birth Sex: M F Weight when diagnosed with renal failure (or nearest estimate) kg Height cm 2.2 Ethnicity - Please tick as appropriate White British Irish Any other White background Black or Black British Caribbean African Any other Black background Mixed White and Black Caribbean White and Black African Chinese or Other Ethnic Group Chinese Any other ethnic group (please specify) White and Asian Any other Mixed background Not stated Asian or Asian background Indian Pakistani Bangladeshi Any other Asian background 2.3 Participant informed consent Date participant signed written consent form Date of blood sample taken Page 4 of 11 International IBD Genetics Consortium

5 Section 3 - Medical History 3.1 Hospital Details Consultant Gastroenterologist Consultant Nephrologist Hospital Hospital Hospital address Hospital address Consultant telephone Consultant telephone Consultant Consultant 3.2 Comorbidities Yes No Hypertension Yes No Date of diagnosis Diabetes Yes No Date of diagnosis Type I Using insulin: Yes No Type II Date commenced insulin Severe peripheral vascular disease Yes No Date of diagnosis Other significant medical history Yes No If yes, please give details here International IBD Genetics Consortium Page 5 of 11

6 Section 3 - Medical History 3.3 Smoking History Never Smoked Ex Smoker Current Smoker Start Date End Date Maximum number of cigarettes per day Section 4 - PPI History 4.1 Brand of PPI taken Date started Date stopped Maximum dose Omeprazole Pantoprazole Lansoprazole Esomeprazole Rabeprazole Other (please specify): 4.2 Family history Family history of PPI induced nephritis: Yes No Unknown If yes, give details Page 6 of 11 International IBD Genetics Consortium

7 Section 5 - Renal History 5.1 Presentation Did the patient present because of: Opportunistic blood test Clinical manifestation of renal failure 5.2 Pre-existing renal disease Any known pre-existing renal disease Yes No Unknown 5.3 Baseline renal function Latest renal function (creatinine and egfr) prior to starting PPI [with the normal reference range please] Date of latest renal function prior to starting PPI 5.4 Abnormal renal function Creatinine (µmol/l) Normal range as per lab report egfr (ml/min) Date Urinalysis Date Renal function first abnormal Abnormal renal function first recognised Worst renal function Worst Creatinine clearance 5.5 Recovered renal function Creatinine (µmol/l) Normal range as per lab report egfr (ml/min) Date Urinalysis Date Best recovered renal function Time to best recovered renal function (days) International IBD Genetics Consortium Page 7 of 11

8 Section 5 - Renal History 5.6 Action taken Drug withdrawn Date Dose decreased Date Reduced dose Tolerated (normal renal function on this dose) Not tolerated Not known 5.7 Peak blood eosinophil count (within 3 months of abnormal renal function being recognised) Date Count (x10 9 /L) 5.8 Renal biopsy Yes No If yes, date of renal biopsy Histology of renal biopsy 5.9 Was the patient re-challenged with a PPI? Yes No If yes, which PPI was used? Date started Outcome: Tolerated Dose tolerated Not tolerated Lowest Creatinine/eGFR (with date of test) Date of drug withdrawal Page 8 of 11 International IBD Genetics Consortium

9 Section 5 - Renal History Proton Pump Inhibitor Induced Nephritis 5.10 Treatment of interstitial nephritis Were steroids used? Yes No Date steroids started? Dose Date steroids stopped? Were any other immunosuppressants used? Yes No Name of immunosuppressant used and dose Date started? Dose Date stopped? 5.11 Other treatment for renal failure Did the patient require dialysis? Yes No Unknown If yes, date dialysis commenced Date dialysis ceased Was this haemodialysis or peritoneal dialysis? Was dialysis temporary or permanent? Did the patient require renal transplantation? Yes No If yes, date of transplantation 5.12 Comments International IBD Genetics Consortium Page 9 of 11

10 Section 6 - Other Drug History (in 12 months prior to development of renal impairment) Drug Route (oral/pr) Dose Start date mm / yyyy Stop date mm / yyyy Non-renal side effects Page 10 of 11 International IBD Genetics Consortium

11 Section 7 - Principal Investigator Statement I have reviewed this CRF and confirm that, to the best of my knowledge, it accurately reflects the study information obtained for this participant. All entries were made either by myself or by a person under my supervision who has signed the Delegation Log. Principal Investigator s signature Date Principal Investigator s name (print) ONCE SIGNED, NO FURTHER CHANGES CAN BE MADE TO THIS CRF WITHOUT A SIGNED DATA QUERY FORM International IBD Genetics Consortium Page 11 of 11